The Group plc interim results investor presentation. Throughout this live presentation, investors will be in listen-only mode. Questions are encouraged and can be submitted at any time using the Q&A tab situated on the right-hand corner of your screen. Please just simply type in your question and press send. Given the significant number of attendees at today's meeting, the company will not be in a position to answer every question it receives during the meeting itself. The company will review all questions submitted today and publish responses where it's appropriate to do so. These will be made available to you via your Investor Meet Company dashboard, and you will receive an email notifying when they are ready for your review. I'd also like to remind you that this presentation is being recorded. Before we begin, we would like to submit the following poll. If you'd be so kind as to give it your attention, we would be most grateful. I'd now like to hand over to Tony Gardiner, CFO, and Alastair Smith, CEO from Avacta. Good morning, sir. Thanks very much. Thanks very much indeed. Good morning, everyone, thank you for attending. We're going to just switch our cameras off actually, 'cause that'll make the presentation slightly larger on your screen. Please don't take that as rudeness, but it'll be easier for you to see. There's a lot to get through today. I'm just gonna pile straight into the presentation. You've got Tony Gardiner and myself on the call, as was just said. As you know, as I said in the announcement this morning, it has been a genuinely transformative period for the G roup, with both divisions moving the Group substantially closer to the mission here of shaping the future of medicine with our two powerful therapeutic and diagnostic platforms. As a brief introduction, for those who aren't familiar with the company, Avacta Group has two divisions. The Therapeutics Division, which is now a clinical-stage oncology drug company based in Cambridge, and new offices in London, giving us a global outreach, a global headquarters for the Therapeutics Division in White City. An R&D center in Cambridge of around 35 people. Clinical development team that's been recently established by Neil Bell and Fiona McLaughlin and taken the AVA-6000 drug into the clinic. Obviously, we'll talk a lot more about that through the presentation. We have an in-house preclinical and clinical pipeline focused on oncology and obviously developing drugs based on those two platforms that we mentioned, and we'll talk more about specifically the pre|CISION platform in this presentation because of AVA6000. And a number of global partnerships which I can update you on the key ones certainly in this presentation today. The diagnostics division also has gone through an incredible growth period over the last 12 months or so to become an ISO 13485 accredited IVD product company with the first product launched, the AffiDX SARS-CoV-2 antigen lateral flow test, which obviously we'll cover in this presentation. Again, an R&D center and in fact, the group headquarters based in Wetherby in Yorkshire. A strong in-house product pipeline to feed in behind that first product that we just mentioned, and a number of global technology evaluations and partnerships. Okay, Tony, could I hand over to you to go through the results please? Thanks, Alastair, good morning, everyone. The interim results are for the six-month period to the 30th of June. The revenues reported of GBP 2.3 million did not include any sales of the AffiDX lateral flow test, as that was launched post period-end, that compares to GBP 1.8 million for the six months to June 2020. Our main costs are the research and development costs for the AffiDX lateral flow test and the expanding therapeutics development pipeline, which obviously includes the commencement of the AVA6000 phase I clinical trials, which included GBP 6.7 million of costs there in the P&L compared to GBP 4.2 million in the prior period. That means that our retained losses following an allowance of GBP 1.2 million for R&D tax credits, of GBP 10.2 million, compared to GBP 7 million for the prior period. In terms of accounting policies together with accounting judgments and estimates, these results have all been prepared on a consistent basis with those that from the audited results for December 2020. If I move on to the cash flow and balance sheets, the net cash outflow for the six-month period was GBP 10.9 million, which includes a GBP 1.4 million increase in our working capital as we scale up the AffiDX lateral flow test manufacturing and the setup costs associated with that. Alongside that, there's circa GBP 800 thousand of CapEx as we have expanded the lab facilities in Wetherby and Cambridge. The comparative period showed a net cash inflow of just under GBP 46 million. That's obviously as a result of the fundraising that was completed back in June 2020. Importantly, cash and short-term deposits at the end of June were just a tad under GBP 37 million, compared to GBP 48 million at the end of December 2020. The cash position continues to provide us with a base cash runway through into 2023, and obviously additional cash and profit generated from the AffiDX lateral flow tests will strengthen this position further. In terms of other balance sheet items, PPE and lease assets is just under GBP 5 million, and intangible assets, which is mainly the capitalized development costs of the Affimer platform, amount to GBP 9 million, which gives us a net asset position at the end of June of GBP 53 million. I hand back over to Alastair to continue the presentation. That's great. Thanks, Tony. Okay. I want to initially focus on the AVA6000 phase I clinical trial because of the obvious significant value driver that it is for the group over the next 6 - 9 months. First of all, let me remind everyone, or perhaps for some people, introduce the pre|CISION technology. The pre|CISION technology is a highly specific, what's called a substrate for an enzyme called FAP-alpha. Okay. The function of an enzyme is to cut biological molecules, and it cuts what is called a substrate. pre|CISION is the substrate for FAP-alpha, which is an enzyme that's highly upregulated in solid tumors. This particular enzyme is found in large quantities, in high concentration in solid tumors. You see on the right, I won't read through that, but the graph on the right shows you the amount of FAP-alpha in certain solid tumors. Clearly there are some where that particular enzyme is expressed very highly. It is expressed or produced in very low quantities in healthy tissue. This particular enzyme is effectively tumor-specific, although there is a low background level in healthy tissues. The pre|CISION substrate for that enzyme is highly specific to that enzyme. That's really where the IP lies. This is IP that we exclusively license from Tufts University School of Medicine in Boston. The reason that is so important, because other companies and academic groups have tried to harness the enzymatic activity of FAP in the past, but have largely failed because they couldn't get the specificity to that particular enzyme because there's a number of other enzymes that are very closely related but are distributed all around the body and are not specific to the tumor. The key here is that pre|CISION is absolutely specific to this tumor enzyme. When you attach the pre|CISION chemistry, and I'll show you what that looks like on the next slide. When you attach that pre|CISION chemistry to a chemotherapy, a chemotoxin, it prevents that drug from getting into cells, making that drug effectively inert until it gets into the tumor where it encounters the FAP-alpha and the FAP-alpha cuts off the pre|CISION chemistry. Remember, the function of an enzyme is to cut biological molecules. When the drug modified with pre|CISION gets into the tumor and encounters FAP-alpha, the pre|CISION chemistry is removed, releasing the active chemotherapy. The pre|CISION chemistry can also be incorporated into the linker of what is called a drug conjugate, where you use an Affimer or an antibody with a linker to a toxin or indeed a radiopharmaceutical to be able to add additional targeting or even therapeutic benefit through the Affimer or the antibody. The pre|CISION chemistry can be added into the linker to release that warhead or chemotoxin in the tumor microenvironment. There is huge potential for this platform, providing of course that we can get positive data from the phase I study that we've just initiated, which is obviously our focus in this part of the presentation. Just to go into a little bit more detail and using AVA-6000 as the specific example. On the left-hand side, you see what I've just described in words but in pictures. The AVA-6000 is a pre|CISION modified form of doxorubicin. Doxorubicin is a chemotherapy we'll talk about in a moment. It's been around for many years, and it is highlighted there with the blue circle. That is the chemotherapy. In the red circle is the pre|CISION chemistry. It's for those who know about these things, it's a small dipeptide, and it is chemically linked to doxorubicin to create AVA-6000, what we call a prodrug, which as we said on the previous slide, is inert at that point because it can't get into cells to kill them. The tumor microenvironment is a very complex environment with many different types of cells. It's a complex milieu of different cells, and it's the fibroblasts and some cancer cells where the FAP-alpha resides. It's those upregulated FAP-alpha cells that the prodrug encounters the enzyme on the surface of those cells. You see on the right-hand side, certainly in cartoon form, that the FAP-alpha behaves like a pair of scissors, removes the pre|CISION chemistry from doxorubicin, and you'll notice that it leaves doxorubicin itself. It's not a modified form of doxorubicin. It is the drug doxorubicin when the pre|CISION chemistry is removed. That's important in terms of the regulatory pathway through to market approval. It leaves doxorubicin, which is now, of course, active, able to enter cells in the tumor. You effectively here have a way of releasing, if you like, or activating the chemotherapy within the tumor and reducing the side effects, reducing the exposure from a systemic perspective in healthy tissue. Just to emphasize that point finally, if you look on the left here, this represents the situation with a standard systemic dosing with the chemotherapy, which is that all the organs in the body, as well as the tumor, are exposed to the chemotherapy. Of course, it's that damage to healthy tissues that leads to poor tolerability for patients. That's a problem across the board for chemotherapies, not just doxorubicin. It's that systemic exposure and systemic safety that causes the issue with these drugs, which are generally efficacious. On the right-hand side is the situation with the pre|CISION prodrug systemic dosing. Here, it's AVA-6000 that is dosed systemically, which as we've talked about is inert until it, through the circulation, gets into the tumor and encounters FAP-alpha where the chemotherapy is released. The principle is that healthy tissues should receive much lower exposure than the tumor tissues, improving the tolerability and safety, and therefore efficacy for the patient. A little bit of background on doxorubicin and AVA-6000, just before we go on to talk about the clinical trial and progress in that regard. As we've said, AVA-6000 is a pre|CISION prodrug of doxorubicin. It's a generic drug, been around for a long period of time, standard of care for soft tissue sarcoma and a few other indications. Its use is limited by the serious safety issues, which are primarily cardiotoxicity, but also myelosuppression. Myelosuppression means effectively suppression of the immune system. Nevertheless, despite those issues with the drug, it's a billion-dollar generic drug market. Clearly there is a significant opportunity for a form of doxorubicin that has significantly improved safety, allowing patients to be treated with a larger number of cycles. The principle here is not necessarily to treat the patient with much higher doses, but to be able to treat the patient over a much longer period of time, because it's the cumulative toxicity that prevents that from happening with doxorubicin. On the right-hand side of this slide, you'll see 1 small part of the preclinical data package. Obviously it's the reason that we are so excited about the potential for the pre|CISION platform and for AVA6000. On the left of that graph, you see the situation in this animal model when the animals are dosed with standard doxorubicin. You see what you would expect to see, which is the concentration of doxorubicin in the heart, shown in pink, and in the tumor is roughly equal. A one-to-one ratio, because you're dosing the animal with doxorubicin, it's systemic, the heart is receiving the same exposure as the tumor, which as we've discussed, is the issue here. On the right-hand side is the data for AVA6000, but it's showing the amount of released doxorubicin. Okay? In pink, you see that this dose of AVA6000 is 6x the dose on the left-hand side of doxorubicin. We've increased the dose by a factor of six, and you start to see some doxorubicin appear in the heart, because as I said, there is a low background level of FAP-alpha, very low, but nevertheless, there is a low background level. You start to see some appearance of the doxorubicin in the heart tissue. At that point, you have nearly 20 x the concentration of doxorubicin in the tumor tissue. It's that improvement in what we call the therapeutic index that is key and is obviously what's driving our excitement around the pre|CISION platform. There's a significant potential market as we said. We've done quite a bit of work trying to understand that market and continue to do that, by the way, but we think it's a significant market, with potentially a 5%-10% royalty to Avacta through a licensing deal with development milestones along the way. Quite a significant commercial opportunity for AVA-6000 alone, but we'll talk about the broader pipeline in a moment as well. I have to stop saying transformative. I keep saying it over and over again, it has genuinely been a huge step forward for the company becoming a clinical-stage oncology drug company with the dosing of the first patients in August. Neil and his team did an outstanding job of getting the CTA filed by the end of 2020. We received approval for the phase I study, which I'll describe in a moment from the MHRA during the reporting period, an ethics approval, and have gone on to dose first patients in August at the Royal Marsden. We will very shortly have three more sites online. The first patient has been dosed multiple times at the Royal Marsden. It would be wholly inappropriate for me to go into any detail about that at this point. In terms of when will we be able to provide the market with an update, we've said consistently towards the end of the year into Q1, that's the sort of time we'll have gone through multiple dose escalation cycles, which I'll describe in a moment. This study has been designed to be extremely data-rich around PK/PD, all the safety indicators that you would expect because of course, not only does this add value to the AVA-6000 asset, but it adds value to the whole pre|CISION pipeline that follows on behind it. Having as much data as possible around how the pre|CISION substrate behaves in humans is key to this study. The dose escalation phase is the initial phase which will complete in Q2 next year. That's designed what's called a 3+3. Effectively three patients are dosed at the starting dosing level, which is 80 mgs per meter squared for AVA6000, which equates to 54 mgs per meter squared doxorubicin. For information that is just below, it's 90% of the normal doxorubicin dosing level. That is a level where we would expect to see safety issues, the normal safety and tolerability issues with doxorubicin. The first cohort is not being dosed at a tiny fraction of the normal level. The first patient was dosed and has been dosed multiple times, and I can't say any more at this stage, obviously, other than we're very pleased with the positive progress at this stage. What happens beyond the first cohort is that the dose is escalated to a higher level. That level will be determined by the investigators at the clinical trial sites and our medical advisor. Another cohort of three patients will receive that higher dose, and so on, until, again, the investigators, the medical advisors determine the maximum tolerated dose, and the recommended phase II dose for the dose expansion phase I-B. We expect to go through approximately four cohorts, 12, maybe 15 patients, during the next couple of quarters. By the end of Q1, we will have a huge amount of data describing the PK/PD safety, and so forth for AVA-6000. The dose expansion phase follows on from that, where we will focus on two or possibly three particular cancer types, and look at a larger number of patients, 15- 20 within each of those cohorts. That phase I-B part of this study will take approximately a year. I mentioned a couple of times the pipeline that sits behind AVA-6000. I think it's worth just reiterating this because positive data from the phase I study that we just talked through in the next three, four months or so not only creates a potentially very valuable and proprietary form of doxorubicin, but also indicates that the pre|CISION platform is working as we expect. We've recapitulated the animal data in human. That opens up the potential to use the pre|CISION chemistry with a significant pipeline of other chemotherapies. This is not just a single drug asset opportunity. It is a platform in a market worth nearly GBP 57 billion and growing quite rapidly. Of course, as we've said several times, limited by the tolerability and the safety of the drugs for patients. Just a couple of examples. Velcade is what's called a proteasome inhibitor. Takeda's Velcade is a small fraction, about 30%, if I remember correctly, of the proteasome inhibitor market. It has limited approval due to the dose-limiting toxicities coming off patent as well next year. We have been working on a pre|CISION form of Velcade, which we call AVA3996. We have set ourselves the objective of selecting a clinical candidate for that prodrug to be developed and taken into the clinic. That objective is to have that clinical candidate selected by the end of this calendar year. I'm pretty confident we're going to achieve that. We're getting very close to that point. Good progress on the 3996 program to date. Other potential pre|CISION prodrugs that could be developed. We just chose another example there of paclitaxel, one of the taxanes. Very large market. Again, significant toxicities, myelosuppression, peripheral neuropathy, and so on. On the right-hand side, that's a sample of the pipeline of precision chemotherapies, prodrugs that could be developed. The pro-Velcade, well advanced, as we just described. paclitaxel, oxaliplatin, gemcitabine, all being reviewed in detail now to determine which of those would be the next one to develop in the pipeline. Okay. Just to round up on partnerships as well, which are immensely important to us. Certainly the LG Chem partnership. I mean, LG Chem is a world-class, a global, fully integrated pharmaceutical company. I'm sure those of you who've heard me speak several times will know that we regard this as a very important strategic partnership with a pharmaceutical company that can manufacture and take drugs to market. We have a multi-target agreement with them to develop a number of Affimer therapeutics in different disease areas. That partnership was expanded last year to include our Affimer-XT technology, which I'll explain briefly in a moment. Very recently, yesterday in fact, we announced a significant milestone had been achieved in that the Affimer-XT PD-L1 bispecific that we've been working on with LG Chem passed through a development milestone, and LG Chem will be developing that pre-clinically with a view to IND filing. That triggered an undisclosed milestone payment. Just to go back and explain, for those of you who aren't aware what Affimer-XT is, if you have a relatively small drug, like an Affimer or a PD-L1 antagonist that's just an Affimer, then it will get cleared through the kidneys relatively quickly, in an hour or so, in fact. For most drugs, you want a longer exposure than that. What we have done is develop Affimers that bind to human serum albumin, which is a large protein that's in very high concentration in blood, and it's too large to be cleared through the kidneys. Affimer-XT binds to that serum albumin, and if you then bind the PD-L1 Affimer to the Affimer-XT, it will, if you want to use that phrase, piggyback around the circulation on serum albumin too big to be cleared through the kidneys, and you can achieve many days, if not a couple of weeks, of serum half-life for that PD-L1 antagonist. The benefit of doing it like that is that you've still got a very small biological drug, which can therefore penetrate tumor tissue, in principle. That's certainly the belief, penetrate the tumor tissue more deeply. I think it is hard to overestimate the importance of that progress with LG Chem. We now have a major pharmaceutical company taking a bispecific Affimer therapy into full preclinical development alongside our own parallel programs in-house with the Affimer platform. The Point license, which we achieved very early in the reporting period, was to provide Point with access to the pre|CISION platform for the development of tumor-activated radiopharmaceuticals. A very hot area at the moment, as some of you will be aware. The first program has been initiated. We're not directly involved in the work. It's a license we've provided to Point, but that first program has been initiated. The ADC Therapeutics collaboration, we provided ADC Therapeutics with Affimer reagents against the targets of interest. They have decided not to take that program forward following the evaluation, so that will not be taken forward. The Daewoong partnership, we've made enormous strides actually with Daewoong over the last year or so. Early in the reporting period, we successfully raised money for AffyXell with Daewoong of around $7.3 million with a number of significant VCs in South Korea and Southeast Asia. We have generated Affimer molecules against the first two targets in that program with AffyXell with Daewoong, and have very good progress with the in vitro and in vivo characterization of those lead Affimer molecules and the engineered mesenchymal stem cells. Just very briefly, because it is, I think, a really interesting and potentially hugely valuable, but really interesting concept that Daewoong are working with us on here. The mesenchymal stem cells, we demonstrated that we can modify those stem cells to produce and secrete, so spit out, if you like, Affimer therapies so that the stem cell not only has its own therapeutic benefit, but it can be supported by immunomodulatory Affimers in situ in the patient. It's a really novel, next generation stem cell therapy. As I say, really good progress so far with both the AffyXell programs and the mesenchymal stem cell programs with Daewoong Pharmaceutical. Very briefly, I won't read through the bios of the three individuals you see on your screen. Absolutely delighted to have got three people of this Calibre to join our scientific advisory board for the therapeutics division. Professor Spicer has a world-leading phase I clinical trials center in London. Professor Komanduri is an extremely well-known immunologist with a focus on T-cell immunology in cancer. Dr. Champiat works at the Gustave Roussy in Paris. Again, hugely well-known, many clinical trials are in progress or completed with very large pharma and biotech. He's extremely well-known physician in France with a real focus around immunotherapy toxicity management. Three really world-class individuals join the scientific advisory board for the Therapeutics Division to give us advice strategically on pipeline decisions, but also obviously input to the clinical studies. Excuse me. Very conscious of time. Moving on to the Diagnostics Division. I don't think you will need any reminding that we have now become an ISO 13485 accredited IVD product company with the first product launched, which is a SARS-CoV-2 antigen lateral flow test. The AffiDX brand is the diagnostic product brand, not just this particular product brand. It's the diagnostic product brand and will be the brand for the pipeline of products coming out over the subsequent years. The antigen test itself, we've talked many times about what these lateral flow tests are intended to do. They're intended to identify infectious individuals and do that obviously accurately, and in a short period of time. It's a 20-minute test, to identify those individuals who are likely or more likely to transmit the infection to others. The key features and benefits, I'll focus on the left-hand side of this slide, actually. Interesting, I can now give you, of course, some real-world commercial feedback from the market on what our customers are interested in as far as differentiating the product from the many other tests that are out there in the market. It's a crowded marketplace, which obviously presents its challenges, but fortunately, we have a high-performing and differentiated test that allows us to start to win market share in that crowded market. Really on the left-hand side are the key benefits. One actually that's a surprise to us, which I'll mention in a moment. First of all, patient-friendly. There's no doubt that the fact that it's a very simple nasal swab, so swabbing of the nostrils and not a nasopharyngeal test, which is very unpleasant, as I'm sure everybody has experienced. That is a big selling point. As you know, many of the tests on the market are nasopharyngeal tests. In order for them to convert to nasal tests, they have to go through further clinical validation and obviously regulatory marking. That's a really good differentiating benefit. The performance, of course, is a major plus, and we'll talk a little bit more about that and the further data that we've obtained more recently as well. A high-performing test, certainly amongst the best. It's difficult to say that it's the best, but it's certainly amongst the best on the market in terms of sensitivity up to a high CT value, low viral load that we'll talk about in a moment. Interestingly, there is a huge focus on the Delta variant, much less so on the other variants. Obviously, Delta has become the dominant variant globally, but nevertheless, we don't get much in the way of questions or inquiries about other variants, but the Delta variant is hugely important, and I think Avacta is unique in having published its data specifically on the Delta variant. I'm certainly not aware of any other lateral flow test that has specifically said that it can detect the Delta variant or published any data, and that data is on our website. 12 patient samples that were fully sequenced to identify the Delta variant. We have very good performance in detecting that dominant variant with the test. The fact that it is a U.K.-developed test is very important to customers, obviously, particularly in Europe and the U.K., but generally actually, in the APAC region as well. The fact that it's U.K.-developed is really important, and the fact that it's manufactured in the U.K. as well. The fifth one that's not on there, which a little bit of a surprise to us, but interesting and very nice to hear, is that customers are really interested that it has a new technology in it, the Affimer platform. We didn't anticipate that that would be something people would focus in on. They would focus in on the performance. They are less concerned about the technology under the bonnet. Interestingly, it's become a real point of interest, and therefore something we push on in the business development, the fact that there is a novel platform which has given this test excellent performance. This is data that most of you will have seen before. This is the regulatory data submitted in the technical file in the IFU. I will just highlight the fact that the point I made earlier on about good performance, excellent performance in the infectious range. Many tests are talking about CT values of 25 and below as the infectious range. We do not believe that is sufficiently sensitive. People with a PCR CT value of viral load up to 30 are certainly infectious if they're in an enclosed environment or intimate with someone for a period of time, then that is an infectious viral load. Simply saying 20 and below is good enough is not true. The AffiDX SARS-CoV-2 test has very good sensitivity for 27 and below, which is where we have set the sort of benchmark of infectious, but even in the higher 20s, very good performance as well. To be frank, anything above 90% when you're up at 30 would be very good indeed. In terms of specificity, again, the regulatory data is in the table there, 99% over 100 samples having this one. Just in the footnote there, but to explain to you, we've done a further roughly 130 odd negative samples since to define that decimal place better, and we continue to take more negative samples as well. The specificity now is at 99.6%, which is clearly important if you're doing very large numbers of tests and the false positive rate is obviously important because it has an impact on the individual that takes the test. The current manufacturing capacity at GAD is around 1 million tests per month. In principle, that can be scaled actually, but I just want to give you the facts of where we're at right now, around 1 million tests per month. The manufacturing process has been transferred to Abingdon Health. We're now going through what's called the validation batches. Those are three batches that obviously should be identical. That is going on now. Those should be saleable product, but the point is that the process has been transferred to Abingdon, and we're now into that final validation stage, which should be saleable product. Abingdon Health could add a further 1 million-2 million tests per month. Indeed, that is scalable. We are well advanced, actually, in putting in place both European and potentially, if we need it, Asian manufacturing that would make a very significant difference to those numbers. Obviously, we're going to be driven by the growth in sales and demand. We do have both of those capacities in Europe and Asia well advanced to switch on when we need them. From a sales perspective, we are making direct sales ourselves to large corporates for workforce testing, to elite sports clubs, into the travel industry and testing services. There's a lot of companies now providing testing services in U.K. and Europe. Those are our key areas of focus. Large individual sales rather than small sales, which we're doing through distributors. Calibre Scientific, you'll be aware, we announced recently as the first U.K. E.U. distributor. We are speaking with Calibre about other territories, actually, and we have ongoing work with distributors in the APAC region. You can see in the bubble to the right-hand side, the reason that is driving our strategy is because the APAC region accounted for a very significant part of the SARS-CoV-2 antigen test sales in the last year. We are working with distributors in the APAC region to get the additional regulatory approval. CE mark gets you a long way, but there is local regulatory approvals, as you would imagine, that are not too onerous to get, but working with the distributors to open up those markets as well, which are clearly very significant. Although it's the last bullet point on the page, it's by no means the least, in fact, probably the most important bullet point on this page, actually. We've been saying for a long period of time that the ability to do self-testing is key to the commercial success here. Professional use tests, although the rules are obviously being stretched under the pandemic circumstances as to how professional use tests are used, clearly a self-test with a CE mark for self-testing opens up a very significantly larger market. Medusa19 have done an outstanding job, actually, of taking the technical file through regulatory submissions to a notified body in Europe. That decision process obviously sits with the notified body, and that is not in our control. I can't give you a precise timing of when we would expect to get the CE mark for self-test. I think we are making very good progress in that regard. Just to go through a summary and some closing comments then. I'm trying not to say transformative too many times, but it genuinely has been a challenging, of course, but a very significant period of growth and progress for both of the Avacta divisions to take the diagnostic business from a business that was largely focused on partnering to get Affimer reagents into partners' product pipelines, which we're still doing with companies like Biokit and so on. To take that, and under the circumstances of the pandemic as well, to be an ISO 13485 accredited IVD product company in the last year, launched the first product, and have a significant commercial opportunity for that professional use test. Obviously, as we just mentioned, potentially even greater market opportunity for the self-test when it arrives. That I think is, whilst it's been bloody hard work, it is a real achievement. We have significant capacity in the U.K., now the opportunity to expand that both in the U.K. and overseas. Very pleased with that. The focus is around direct sales ourselves and distributors, U.K., EU, private sales, and particularly, for us, getting distributors on board in the APAC region. From a therapeutics perspective, I've had a personal goal for a long time in Avacta of getting this division to be a clinical stage company. Personally, and obviously for the company, extremely pleased to achieve that goal, and to have dosed first patient with what I sincerely hope is a transformational platform to develop a number of chemotherapies, 6,000 and beyond, which are, of course, affordable cancer therapies. Many immunotherapies, Affimer-based or antibody-based, are much more expensive to develop. Of course, chemotherapies are very affordable. If we can contribute to this field by reducing the side effects and improving the tolerability of chemotherapy in general, I'm sure you can see that is a value driver way beyond what we're going to achieve with COVID test sales. We're aiming for an IND filing for AVA-6000 before the end of 2021. I am currently confident that we will achieve that. That will lead into a clinical study in the U.S. We have two clinical trial sites identified. We've just achieved that milestone, as we discussed with LG Chem, which means they will take an Affimer bispecific forward through preclinical development with the goal of IND filing and taking that into the clinic themselves in parallel to our own AVA-28 program. AffyXell, well funded to hit the next milestone in the middle of next year. We have a number of development candidate selection milestones across our programs and with partners during the next 12 months to drive news flow. I'll leave it there if I can. Of course. Thank you very much indeed to both Tony and Alastair for updating investors. Ladies and gentlemen, please do continue to submit your questions using the Q&A tab situated on the right-hand corner of the screen. Just ahead of going into the Q&A, I'd like to take a few moments to remind you that a recording of this presentation, along with a copy of the slides and the published Q&A, can be accessed via your Investor Meet Company dashboard. As we said, we will notify you when the significant number of questions that have been submitted have had an opportunity to be gone through. I'd also like to remind you that your feedback is important to the company. Immediately after this presentation is ended, we'll redirect you for the opportunity to provide your feedback in order that the company can really better understand what your views and expectations are. As I mentioned, there are a significant number of attendees on today's call. We did receive both a number of questions ahead of the event and obviously during this event. I think what the company have done is to try and allocate a question to perhaps areas or themes of where investors had submitted questions. Perhaps, Tony and Alastair, if I may, I can start off with the first one, which reads as follows: How are you following the pharmacokinetics and toxicology of the cleaved non-doxorubicin part of the AVA6000? Okay. Yeah, that's an interesting question. We are measuring the levels of AVA6000 doxorubicin and the cleaved substrate in plasma and urine using HPLC. There's no time to explain what that is, but there's a straightforward way to do that over a 72-hour period post-dose. That allows us to look at those compounds and how they're eliminated from the body over time. From a tox point of view, the non-doxorubicin part, what we call 5140, we've assessed that in animal tox and in silico, and there's no indication there should be any tox issues, and we'll obviously follow that in the phase I escalation phase. Thank you very much indeed, Alastair. Next question reads as follows: When will shareholders be given an indication as to how the AVA6000 dosing and early readings are going? Yeah. I've given certainly positive guidance today. It would be totally inappropriate to talk about the data at this point, given that there's a 1 patient that's been dosed. It's very early in the process, but we're feeling very pleased. We're going to open up new trial sites very soon, actually, which will increase the flow of patients into the study. There is no concern at all with the investigators about patient numbers. We expect to remain on the schedule for Q1. We will update the market as soon as we possibly can. For example, escalating the dose and starting the next cohort is a strong indicator that the investigators and the medical advisors are happy with the safety. We'll communicate that. As I think I said earlier, while cardiotox is key, and we can monitor that with ECG and so on, and other biomarkers, there are other things like neutropenia, which is a drop in the level of certain immune cells, which are really straightforward to measure, and they're a good early surrogate for safety. We'll be monitoring that as well. By the time we get into Q1, we really should have quite extensive data to update the market with. That's great. Thank you very much indeed. Moving on to the next question. When is home use authorization expected for the AffiDX LFT? Can the company provide clarity as to what specifically is involved in this process that's taken so long? Yeah. It's really important. Obviously wanted to answer this question, which a lot of people have asked. First of all, we've talked about the regulatory process before, but just to recap, there's an additional study called a lay user study, which really focuses on the usability of the test. It's not a clinical validation, it's the usability. That data, which Medusa19 carried out, that is combined with the technical data for the performance of the test itself. Then that full technical file was submitted to the notified body for review. Unlike the self-declaration for the professional use test, the CE mark for the self-test is conferred by the notified body. We have to wait for that. Medusa19's led that process, and as I said in the presentation, they've done a really outstanding job. The question, I don't know whose it is suggesting that it's taken a long time. I think you'll find that notified body review can take many months, even under normal times. Making the progress that has been made is not, in my view, taking a long time. I sincerely hope that we are close to having that CE mark, we are in the hands of the notified body at this point. That's great. Thank you very much indeed. Why has there been what appears to be no commercial interest in the take-up of COVID tests developed by Avacta, particularly as the company has reported such outstanding success in trials? It's just not true at all to say there's no commercial interest. Hopefully what we've talked about today gives more information around that. We're clearly not the first test to market. As I said, there's a crowded market, but fortunately, we have a very good test, which is allowing us to build market share, and that will take some time. For now, we need to focus on marketing, business development, getting the approvals in additional territories, the APAC region in particular, which is really important. Commercial partnerships with distributors, and potentially licensees, actually. We can build the awareness of the product and drive the long-term sales. It's really clear that testing for COVID is going to be around for much longer than I anticipated. I think because of the mutational rate of this particular virus, it's likely to be seasonal for a very long time, maybe forever, like flu. There is a long-term commercial opportunity here, which we will build, and is the basis for a profitable diagnostics division. Thank you very much indeed, Alastair. Turning to the theme around the share price, the next question kind of summarizes it. Would Avacta care to comment on the significant share price decline, and how they propose to address this in the near and long term? Yeah. It's a very fair question. My focus has got to remain on driving the business forwards. Firstly, that means delivering a profitable diagnostics division. Secondly, in the therapeutics division, we need to do all we can to maximize the value of the phase I data for 6000, because as we've said, that drives not only the value of that particular asset, but an incredible pipeline potentially behind it. As I said on a number of occasions, the potential value to Avacta shareholders of the precision platform being shown to work well in human, reducing the side effects of chemotherapy, that dwarfs COVID testing revenues. Whilst the COVID testing revenues and the pipeline of next products is incredibly important to the diagnostic business, the pre|CISION platform, and then the Affimer immunotherapies have the potential to deliver to Avacta shareholders much greater value. We shouldn't, of course, sort of gloss over the importance of supporting our partner programs. That's also really important to address the near term and long-term value, and therefore share price. If LG take an Affimer into the clinic before we do, it will have a huge effect on the value of that platform and the valuation of the company. That's great. Thank you very much indeed. Biodegradable lateral flow cassettes would be a big USP. Do you have any moves in this direction? Yeah. It's a really good question. Yeah, biodegradable cassettes would be actually a significant competitive advantage. It would underline Avacta's commitment to sustainability as well. Not just for this test, actually, for future AffiDX lateral flow tests. Exploratory work is being carried out with our injection molder. I just want to say, it is not a trivial matter of just replacing the existing plastic with a biodegradable one. The cassette is an integral mechanical component that clamps the nitrocellulose test strip in a certain way that controls the sample liquid flow. The physical properties of the new plastic need to be right as well. We're certainly committed to trying to find a sustainable alternative, which would be a big commercial advantage, as you can appreciate. A lot of people uncomfortable with the amount of plastic waste being created, and we are too. As soon as I've got a material update on this, I'll inform shareholders. That's great. Thank you very much indeed. Is there currently a Japanese distributor or manufacturing partner in place for diagnostics or is one being considered? There isn't one currently. The APAC region we've identified as a significant market. Japan isn't top of the list, but is certainly on the list. We're working with distributors in other markets in the APAC region at the moment to get the regulatory approvals. Japan is on the list, but not top of the list. There isn't a distributor yet in place. Thank you. Just turning to the last question, really. Has the company been given any clarity as to why Conifer, who were noted in the 2020 fundraise as a strategic investor, reduced their holding significantly or potentially to zero? Ruweng Conifer remain an important shareholder. I am not quite sure why anyone would think that they've reduced the holding to zero. The holding is 2.99%, and it's on the Avacta website. There are certain threshold holdings that trigger an announcement. Obviously going to 2.99% crossed the 3% threshold, which is why there was an announcement. Can certainly confirm that Ruweng Conifer remain an important shareholder for us and a very supportive one. Well, that's great. Well, thank you very much as we are now coming up to the hour. Firstly, I'd like to thank all the investors that have taken time to submit questions during today's event and the live event. As I did say at the outset, that all these questions, and just given the significant number of questions and attendees on the call, will be available to the company to review. As I say, we will post responses to everybody at the same time, and you'll receive an email notifying that's when it's ready. Tony, Alastair, I know investor feedback is important, and we'll shortly direct all the investors on the call to give you their thoughts and expectations. I guess before doing so, if I could just ask you for a few closing comments. Yeah, of course. Well, as I said, it's been a period of huge progress and firsts for the group across both divisions. We have a commercial stage ISO 13485 IVD product company with the first product launch, which has, for a diagnostic product, the AffiDX SARS-CoV-2 antigen test has huge commercial potential, which could be expanded soon with the consumer self-test as well with Medusa19. On the therapeutics side, the transformation into a clinical stage oncology drug company is a huge step forward. It's drawn a huge amount of focus and attention on the group and the pre|CISION and the Affimer platform actually from pharmaceutical companies and investors. A period of very significant milestones and looking forward, some more very significant value inflection points. I'm looking forward to having the chance to update the market in the coming months. Alastair, Tony, thank you once again for updating investors this morning. Could I please ask investors not to close this session as we'll now automatically redirect you for the opportunity to provide your feedback in order that the company can really better understand your views and expectations. It may take a few moments to complete, but I'm sure will be greatly valued by the company. On behalf of the management team of Avacta Group plc, we'd like to thank you for attending today's presentation. That now concludes today's session. Good morning to you all.